This role involves developing and implementing strategies to introduce new products to the international market. The successful candidate will develop, create and manage a portfolio of Technical Files and Licenses. It will be required to review proposed labelling and marketing materials prior approval for use.

Duties include:

* International Registrations and European Directives: Develop and coordinate a program to ensure all registrations are completed to agreed time scale
* Support a roll out program for existing products and new launches.
* Manage the creation and development of Technical Files in compliance with the Medical Devices Directive.
* Responsible for advising/supporting customers to assure the continued Regulatory Compliance of existing products throughout their life cycle
* Review proposed marketing materials, packaging, Instructions For Use and Label copy for Regulatory compliance
* Manage a program to ensure efficient scheduling of registrations to meet commitments established for development project plans
* Assure continued compliance with regulatory requirements to maintain applicable certifications and GMP/Manufacturing Licences to support Business Strategy
* Responsible for supporting the timely registration of all current and new products with the correct regulatory authorities
* Maintain a knowledge of current and pending relevant regulations and guidance documents and communicate these to the business
* Work with the Regulatory Affairs and Product Safety Manager to identify all applicable key regulatory requirements and opportunities that relate to a product/project to support the development and ultimate successful launch of new products and into new markets

Required:

Experienced in regulatory submissions for Medical Devices or In Vitro Diagnostic Devices